Status:
ACTIVE_NOT_RECRUITING
A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cardiomyopathy, Hypertrophic Obstructive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a 30-week course of mavacamten and the long-term effects of mavacamten in Japanese participants with symptomatic...
Eligibility Criteria
Inclusion
- Age 18 and greater, body weight ≥ 35kg
- Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
- Diagnosed with obstructive hypertrophic cardiomyopathy consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Japanese Circulation Society guidelines
- Has documented left ventricular ejection fraction (LVEF) ≥60% NYHA Class II or III
Exclusion
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening
- History of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to Screening
- Paroxysmal atrial fibrillation with atrial fibrillation present at the time of Screening.
- Persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening
- Treatment (within 14 days prior to Screening) or planned treatment during the study with cibenzoline, disopyramide or ranolazine
- Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of beta blockers and verapamil or a combination of beta blockers and diltiazem
- Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening or plans to have either of these treatments during the study
- ICD placement within 2 months prior to Screening or planned ICD placement during the study
- Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation procedures, or completion
- Prior treatment with cardiotoxic agents such as doxorubicin or similar
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
August 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05414175
Start Date
August 19 2022
End Date
March 6 2026
Last Update
December 4 2024
Active Locations (20)
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1
Local Institution - 0020
Uwajima, Ehime, Japan, 798-8510
2
Local Institution - 0026
Himeji-Shi, Hyōgo, Japan, 672-8044
3
Local Institution - 0016
Kobe, Hyōgo, Japan, 650-0047
4
Local Institution - 0017
Tsukuba, Ibaraki, Japan, 305-0005